Regulatory Affairs specialist
Website Katalyst Healthcares & Life Sciences
Katalyst Healthcares & Life Sciences
Company : Katalyst Healthcares & Life Sciences
Country: United States
Location : Morris Plains, New Jersey
Post: Fri, 31 Mar 2023 06:32:58 GMT
Expires: Fri, 28 Apr 2023 23:59:59 GMT
Apply Job : Apply Online
—————————— Job Description ——————————
This position will be working with multiple business units to develop, update, and improve regulatory affair processes.
Assist the strategy implementation and operations for regulatory affairs activities, including directing development of product registration submission, progress reports, supplements, amendments, or periodic experience reports.
Update and develop procedures for the regulatory affairs in supporting changes in the regulatory landscape, including EU MDR.
Identify opportunity for regulatory affair processes and drive changes to completion.
Have working knowledge in EU MDR
Have working knowledge in Regulatory Change Assessment in
Have working knowledge in US and EU medical device submissions.
Have experience supporting internal and external inspections.
Work cross-functionally and in a matrixed environment.
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